Hydrus Microsent
FDA premarket approval P170034/S005 · decided 2021-06-04
Approval details
- PMA number
- P170034
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Hydrus Microsent
- Generic name
- Intraocular pressure lowering implant
- Applicant
- Alcon Research, LLC
- Date received
- 2020-12-07
- Decision date
- 2021-06-04
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- OGO
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Approval for modified labeling that reflects the findings of the Post-Approval Study (PAS) designated as Continuation of Premarket Cohort PAS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| LEGION System (K191650) | Alcon Research, LLC | 2019-11-01 |